Radicle Revive 24: A Study of Health and Wellness Products on Menopausal Health and Related Health Outcomes

Radicle Science

Status: Enrolling

Conditions: Cognitive Function; Menopause; Depression; Sleep Disturbance; Libido; Fatigue; Anxiety

Treatments: Dietary Supplement: Radicle Revive Active Study Product 4.1 Usage; Dietary Supplement: Radicle Revive Placebo Control Form 4.1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06749288

RADX-P-2414

Details and patient eligibility

About

A randomized, double-blind, placebo-controlled, direct-to-consumer trial assessing the impact of health and wellness products on hormonal health and associated health outcomes in women with menopausal health issues

Full description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants (1) are females, (2) have menopausal health issues for 3 months or longer, (3) have the opportunity to improve by at least 30%, and (4) express acceptance in taking study products and not knowing the formulation identities until the end of the study.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and women who are pregnant or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Enrollment: 500 estimated patients

Sex: Female

Ages: 21 to 105 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
• Resides in the United States
• Endorses less pain as a primary desire
• Selects pain and/or looking to improve their pain as a reason for their interest in taking a health and wellness product
• Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion criteria

• reports being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address and mobile phone number
• The calculated validated health survey (PRO) score during enrollment represents less than mild severity
• Reports a diagnosis of liver or kidney disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports current enrollment in a clinical trial
• Lack of reliable daily access to the internet
• Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
• Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, or MAO

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups, including a placebo group

Placebo control 4.1.0

Placebo Comparator group

Description:

Revive product form 4.1 - control

Treatment:

Dietary Supplement: Radicle Revive Placebo Control Form 4.1

Active product 4.1.1

Experimental group

Description:

Revive product form 4.1 - active product 1

Treatment:

Dietary Supplement: Radicle Revive Active Study Product 4.1 Usage